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INDICATIONS
RITUXAN HYCELA ® (rituximab/hyaluronidase human) is indicated for the treatment of adult patients with:
ê Relapsed or refractory, follicular lymphoma (FL) as a single agent
ê Previouslyuntreatedfollicularlymphomaincombinationwithfirst-linechemotherapyand,inpatientsachievingacomplete
orpartialresponsetorituximabincombinationwithchemotherapy,assingle-agentmaintenancetherapy
ê Non-progressing(includingstabledisease)follicularlymphomaasasingleagentafterfirst-linecyclophosphamide,vincristine,
and prednisone (CVP) chemotherapy
ê PreviouslyuntreateddiffuselargeB-celllymphoma(DLBCL)incombinationwithcyclophosphamide,doxorubicin,vincristine,
prednisone(CHOP)orotheranthracycline-basedchemotherapyregimens
ê Previouslyuntreatedandpreviouslytreatedchroniclymphocyticleukemia(CLL)incombinationwithfludarabineand
cyclophosphamide (FC)
Initiate treatment with RITUXAN HYCELA only after patients have received at least one full dose
of RITUXAN ®
RITUXAN HYCELA is not indicated for the treatment of non-malignant conditions
IMPORTANT SAFETY INFORMATION
BOXED WARNINGS: SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
ê Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving
rituximab-containing products, including RITUXAN HYCELA. Discontinue RITUXAN HYCELA in patients who experience a severe
mucocutaneousreaction.Thesafetyofre-administrationofarituximab-containingproduct,includingRITUXANHYCELA,topatients
with severe mucocutaneous reactions has not been determined
ê Hepatitis B Virus (HBV) Reactivation: HBV reactivation can occur in patients treated with rituximab-containing products,
including RITUXAN HYCELA, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for
HBV infection before treatment initiation, and monitor patients during and after treatment with RITUXAN HYCELA. Discontinue
RITUXAN HYCELA and concomitant medications in the event of HBV reactivation
ê Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab-containing
products, including RITUXAN HYCELA. Discontinue RITUXAN HYCELA and consider discontinuation or reduction of any concomitant
chemotherapy or immunosuppressive therapy in patients who develop PML
WARNINGS AND PRECAUTIONS
Hypersensitivity and Other Administration Reactions
Systemic Reactions
ê Patients must receive at least one full dose of RITUXAN before receiving RITUXAN HYCELA due to the higher risk of hypersensitivity
andotheracutereactionsduringthefirstinfusion.BeginningtherapywithRITUXANallowsmanagementofhypersensitivityandother
administration reactions by slowing or stopping the intravenous infusion
ê Rituximab-containingproducts,includingRITUXANHYCELA,areassociatedwithhypersensitivityandotheradministrationreactions,
which may be related to release of cytokines and/or other chemical mediators
ê Severeinfusion-relatedreactionswithfataloutcomehavebeenreportedwiththeuseofRITUXAN,withanonsetrangingwithin
30minutesto2hoursafterstartingthefirstintravenousinfusion.Anaphylacticandotherhypersensitivityreactionscanalsooccur
ê Severe cytokine release syndrome may be associated with acute respiratory failure and death. Cytokine release syndrome may occur
within1-2hoursofinitiatingtheinfusion.Patientswithahistoryofpulmonaryinsufficiencyorthosewithpulmonarytumorinfiltration
may be at a greater risk of poor outcome. Rituximab product administration should be interrupted immediately and aggressive
symptomatic treatment initiated
ê During RITUXAN HYCELA administration, the injection should be interrupted immediately when observing signs of a severe reaction
andaggressivesymptomatictreatmentshouldbeinitiated.Closelymonitorthosepatients:withpre-existingcardiacorpulmonary
conditions, who experienced prior cardiopulmonary adverse reactions, and with high numbers of circulating malignant cells
(≥25,000/mm 3 )
Please see the following pages for additional Important Safety Information and the brief
summary of the full Prescribing Information, including BOXED WARNINGS.